AB0950 COST-EFFECTIVE THERAPY IN AXIAL SPONDYLARTHRITIS: A COMPARATIVE ANALYSIS OF TWO TREATMENT STRATEGIES
Authors: P. Vasanth, S. Rajendran, A. Jacob Mathew, R. Goel, J. Mathew
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Biologic disease-modifying anti-rheumatic drugs (bDMARDs) remain inaccessible to a majority of patients in resource-poor countries due to high cost. Cost-saving strategies including the use of generic bDMARDs with an early de-escalation schedule instead of continued standard dose or using generic small molecules such as tofacitinib or baricitinib are being explored for the treatment of axial spondyloarthritis (AxSPA). The generic molecules are cheaper in India as compared with the rest of the world. <h3>Objectives</h3> To compare the efficacy, safety, and cost of generic tofacitinib and disease activity-directed early de-escalation schedule of intended copies of adalimumab (ADA), the most commonly used bDMARD available in India. <h3>Methods</h3> In this retrospective study, patients diagnosed with AxSpA in a tertiary care center in India, initiated on tofacitinib (TOFA), and had at least one follow-up visit from January 2021 to November 2022, were included. Patients who received ADA due to moderate to high disease activity with an early de-escalation schedule, during the same period were included as historical diseased controls. Early de-escalation was defined as increasing the interval between 2 doses of ADA by 1 week every 3 months within 12 months of initiation of the drug. The baseline demographic, clinical presentation, and response to treatment and adverse drug reactions were compared between patients on TOFA and ADA. An Ankylosing spondylitis disease activity score (ASDAS-CRP) of &lt;2.1 was considered a good response to treatment. The descriptive data are presented as mean± SD or median (Interquartile range) or percentages. Fisher's exact test and Mann Whitney U test were used to compare categorical and continuous parameters, respectively, between TOFA and ADA. The average monthly cost of therapy was calculated for both groups. <h3>Results</h3> Among 240 patients who received TOFA, 155 patients satisfied the inclusion criteria, while 40 patients received early de-escalation of ADA. The age (33.0±951 and 33.6±13.3 years, p= 0.66), gender [males n=131 (86.8%) and 32 (80.0%), p = 0.32], median disease duration [7 (4-11) and 7 (4.3-11.0) years] and CRP [22.1 (10.2-44.5) and 23.85(14.48-71.50) mg/L, p= 0.32] were similar for patients who received TOFA and ADA, respectively. The frequency of uveitis, peripheral arthritis, and HLA B27 positivity was similar between the two therapies. Majority of patients [124(82.1%) in the TOFA group and 32 (80%) in the ADA group] in both the groups received concomitant conventional DMARDs, while 36 (23.8%) patients on TOFA received prior TNF inhibitors. During a follow-up period of 6 (3-9) months, 129 (86.7%) of 151 patients on TOFA achieved low disease activity or inactive disease status as compared with 37 patients (92.5%) who received ADA (p = 0.42). Adverse drug reaction requiring drug discontinuation was observed in 6 patients on TOFA (transaminitis in 3, herpes zoster in 2, 1 infective spondylodiscitis) and in 5 patients receiving ADA (transaminitis in 4 and abdominal tuberculosis in 1). <h3>Conclusion</h3> Tofacitinib therapy is comparable to the early dose de-escalation strategy of adalimumab in terms of treatment response and safety in Indian patients with AxSPA. <h3>Acknowledgements</h3> I have no acknowledgments to declare. <h3>Disclosure of Interests</h3> None Declared.